Clindamycin Phosphate

Product NDC: 71335-2861
11-digit product format: 713352861
Labeler code: 71335
Product ID: 71335-2861_ab282b37-cfd9-466c-8bf1-6583e15e3961
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Phosphate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA064050
Marketing category: ANDA
Marketing start: 2013-09-17
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 10 mg/mL
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2861_ab282b37-cfd9-466c-8bf1-6583e15e3961
SPL ID: ab282b37-cfd9-466c-8bf1-6583e15e3961
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Clindamycin Phosphate
Generic name: Clindamycin Phosphate
Dosage form: SOLUTION
Route: TOPICAL
Marketing start: 2013-09-17
Marketing category: ANDA
Application number: ANDA064050
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE]; Lincosamide Antibacterial [EPC]; Lincosamides [CS]; Neuromuscular Blockade [PE]
Listing expiration: 2026-12-31

Ingredient	Strength
CLINDAMYCIN PHOSPHATE	10 mg/mL

Package NDC	Description	Marketing start	Sample
71335-2861-1	1 BOTTLE, WITH APPLICATOR in 1 CARTON (71335-2861-1) / 30 mL in 1 BOTTLE, WITH APPLICATOR	2025-10-24	No

UNII	Preferred term	Registry number	Matched term
EH6D7113I8	CLINDAMYCIN PHOSPHATE	24729-96-2	CLINDAMYCIN PHOSPHATE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2861-1	71335286101	1 BOTTLE, WITH APPLICATOR in 1 CARTON (71335-2861-1) / 30 mL in 1 BOTTLE, WITH APPLICATOR	2025-10-24	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate Topical Solution USP, 1%	Bryant Ranch Prepack	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	100